Condition category
Cancer
Date applied
20/12/2013
Date assigned
20/12/2013
Last edited
22/07/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Miss Christina Brindley

ORCID ID

Contact details

Division of Primary Care
13th Floor Tower Building
University Park University of Nottingham
Nottingham
NG7 2RD
United Kingdom
christina.brindley@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

15872

Study information

Scientific title

Proactive familial breast cancer risk assessment in primary care: feasibility of an optimised intervention to improve identification and care of women at risk (Phase 2)

Acronym

Study hypothesis

Some women with relatives previously diagnosed with breast cancer may be at higher than average risk of developing breast cancer. It is important to identify these women so they can benefit from specialist services for early diagnosis and better life expectancy.

National guidelines on how to identify women at familial risk of breast cancer were issued in 2004. However, some women with a high risk, particularly younger women and those from less educated and minority backgrounds, are not being identified. In contrast, other women at average risk are inappropriately referred to specialist services.

This study aims to develop a more systematic approach to identify women's familial risk of breast cancer. The intervention will involve women completing a family history questionnaire already tested for effectiveness combined with practices using decision-making software to calculate breast cancer risk and to better target referral to specialist services. We will compare what happens now (usual care) with a proactive way of identifying women, aged 30-60, with familial breast cancer risk.

This study will:
1) develop and refine the intervention in women aged 30-60 in primary care
2) use a combination of different research methods to begin to understand the benefits to the NHS of using the intervention.

More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=15872

Ethics approval

Nottingham 2, First MREC approval date 27/01/2014, ref: 14/EM/009

Study design

Randomised interventional; Design type: Prevention, Process of Care, Screening

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases

Intervention

General practices are randomised to either the intervention arm (proactively identifying women aged 30-60 and using the decision-support software) or the control arm.

16 women recruited for focus groups 1 and 2 (8 per focus group)
Approximately 35 women from 6 control practices opportunistically identified.
Approximately 350 women from 6 intervention practices = 2100 (however this may be more or less depending onpractice list size).
The interviews following the exploratory trial will involve women already recruited to the study and included in the numbers above.

6-12 GPs for interviews from the intervention group.
6-8 administrative staff for interviews.

Family History Questionnaire, This will be used with decision-making software

Follow Up Length: 8 month(s)

Study Entry : Registration and One or More Randomisations

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Proactively identify women at risk of familial breast cancer; Timepoint(s): Final analysis

Secondary outcome measures

1. Optimise study design for a further trial; Timepoint(s): Final analysis will identify whether this study is successful in meeting its aims.
2. Streamlined referrals to specialist services; Timepoint(s): Measured through participant medical records at 6 month follow-up.

Overall trial start date

10/02/2014

Overall trial end date

30/08/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Eligibility for General Practice anonymised MIQUEST searches:
General Practices in Nottinghamshire who consent to undertake anonymised database searches.

Eligibility for Focus Group 1:
Women with a family history of breast cancer and no previous referral to specialist services, identified through newspaper adverts in Nottingham newspapers. Participants will be aged between 18 to 70 years.

Eligibility for Focus Group 2:
Women identified with a family history of breast cancer with previous experience of specialist services identified through the Royal Derby Hospital. Participants will be aged between 18 to 70 years.

Eligibility criteria for patient participants for the exploratory trial and nested qualitative study:
1. Women aged between 30 and 60 years
2. Registered with a participating GP practice
3. Able to complete the family history questionnaire in English (assistance from a household member is permitted)
4. Have NO history of breast or ovarian cancer
5. Must NOT have undergone a Familial Breast Cancer Assessment at specialist services in the previous 12 months
6. Must not have participated in the focus groups

Eligible health professionals for the exploratory trial are:
Consenting GPs (principals, salaried, registrars), nurses (including nurse practitioners/practice nurses) and administration staff at the study general practices in Derbyshire.

Eligible health professionals for the nested qualitative study are:
1. Consenting GPs (principals, salaried, registrars), nurses (including nurse practitioners/practice nurses) and
administration staff at the study general practices in Derbyshire.
2. Nominated lead GPs involved in providing the information or risk communication/consultation with patients from each intervention practice
3. Designated administrative staff entering the FHQ data into FaHRAS (risk assessment software); Target Gender: Male & Female; Upper Age Limit 70 no age limit or unit specified ; Lower Age Limit 18 no age limit or unit specified

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 2163; UK Sample Size: 2163

Participant exclusion criteria

Exclusion criteria for General Practice undertaking the anonymised MIQUEST searches:
General Practices who do not consent to undertake anonymised database searches.

Exclusion criteria for Focus Group 1:
Women who do not have a family history of breast cancer
Women who were referred to specialist services as part of their NHS care for breast cancer/suspected breast cancer.

Exclusion criteria for Focus Group 2:
Women who do not have a family history of breast cancer
Women who were not referred to specialist services, for familial breast cancer risk, at Royal Derby Hospital.

Exclusion criteria for patient participants for the exploratory trial and nested qualitative study:
1. Women outside the age range of 30-60 years
2. Not registered with a participating practice
3. Unable to provide written informed consent
4. Unable to complete the family history questionnaire in English
5. History of breast or ovarian cancer

Exclusion criteria for Focus Group 2:
Women who do not have a family history of breast cancer
Women who were not referred to specialist services, for familial breast cancer risk, at Royal Derby Hospital.

Exclusion criteria for patient participants for the exploratory trial and nested qualitative study:
1. Women outside the age range of 30-60 years
2. Not registered with a participating practice
3. Unable to provide written informed consent
4. Unable to complete the family history questionnaire in English
5. History of breast or ovarian cancer
6. Undergone a Familial Breast Cancer Assessment at specialist services in previous 12 months
7. Must not have participated in the focus groups.
8. Patients considered by the General Practitioners to be inappropriate to recruit due to psychosocial reasons.

Exclusion criteria for health professionals for the exploratory trial and nested qualitative study are:
GPs (principals, salaried, registrars), nurses (including nurse practitioners/practice nurses) and administration staff at general practices not participating in the study.

Recruitment start date

10/02/2014

Recruitment end date

30/08/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Division of Primary Care
Nottingham
NG7 2RD
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

Research Innovation Services
Kings Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR (UK) - School for Primary Care Research; Grant Codes: Project 206

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes